CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 68 enrolled
Drug / intervention
Regorafenib +2 moredrug
Likely dose
Regorafenib 160 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02175095
NCT02175095N/ACompleted

3'-Deoxy-3'-18F-fluorothymidine Positron Emission Tomography ([18F] FLT-PET) for the Prediction of Response to Regorafenib in the Metastatic Colorectal Cancer Patients Who Progressed After All Standard Therapies

Asan Medical Center·interventional·Posted Jun 26, 2014·Updated Oct 4, 2024

In Brief

A clinical study evaluating Regorafenib, [18F]FLT-PET, and 1 other intervention for Colorectal Cancer. Completed, enrolled 68 participants across 1 site.

Detailed Summary

Regorafenib is approved in the treatment for metastatic colorectal cancer patients who have been progressed after standard therapies, however, there has not been a predictive biomarker. The investigators designed this study to investigate whether \[18F\]FLT-PET might paly a role as a predictive imaging biomarker of treatment responses to regorafenib.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 26, 2014
Enrollment StartJul 18, 2014
Primary CompletionAug 10, 2016
Study CompletionApr 30, 2019
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 12.0 years ago

Interventions

Regorafenibdrug

Regorafenib will be administered 160 mg/day given orally on day 1 to days 21 following 7 days break, which consists of 4 weeks as 1 cycle. Treatment will be repeated every 4 weeks and continued until disease progression, unacceptable toxicity or the patient's refusal.

[18F]FLT-PETother

\[18F\]FLT-PET scans before and on 21st day from the administration of regorafenib.

[18F]FDG-PETother

\[18F\]FDG-PET will be performed before treatment and at 21 days after treatment.